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The QMN Weekly Bulletin

MHRA Fines Two Companies in Defective Syringe Case

Sept. 11, 2015

The UK’s Medicines and Healthcare products Regulatory Agency has successfully prosecuted two companies it says supplied defective prefilled syringes whose use resulted in a diabetic patient’s death in 2010.

Calea UK and its wholesaler Fresenius will pay about $80,000 and $790,000, respectively, after pleading guilty to violations of the Medicines Act of 1968. The fines come as a result of an investigation into the death of Neil Judge, 58, who experienced organ failure after being deprived of insulin for more than 13 hours. The syringe he was treated with at a UK hospital was found to contain no insulin.

During an inspection of the joint Calea-Fresenius site in Runcorn following Judge’s death, MHRA inspectors determined the facility lacked an effective quality management system. The quality problems led to improperly labeled solutions used to compound insulin. As a result, the syringes were filled with extra saline, rather than insulin.

Dosage Issues

In a separate incident, Calea was found to have manufactured prefilled syringes containing Tobramycin, which is used to treat infections, with three times the prescribed daily dose of the drug. No patients died as a result, although one cystic fibrosis patient reported a fizzing sensation following treatment.

“Fresenius Kabi Ltd and Calea UK Ltd are equally responsible for the medicinal failure that was a major contributing factor in the tragic death of Neil Judge, who was deprived of the vital insulin his body needed because of a serious manufacturing error,” said Alastair Jeffrey, MHRA head of enforcement. “I hope this case serves as a clear reminder to others, as MHRA will not hesitate to take enforcement action when serious failings occur.”

MHRA inspectors noticed problems at the Runcorn site two years before Judge’s death. During a November 2008 inspection, they determined these problems were “major” — meaning they could result in a product that does not comply with the marketing authorization or they are a result of a sizeable deviation from EU good manufacturing practices.

However, no “critical” deficiencies — those that could result in patient harm — were found. It wasn’t until the inspection following Judge’s death that critical deficiencies were identified, including the lack of an effective quality management system. The facility still had not remedied this problem by the time MHRA conducted a follow-up inspection roughly six months later.

Critical Deficiencies in 2011

In September 2011, following the Tobramycin incident, inspectors identified additional critical deficiencies. In particular, they cited an issue with unlabeled syringes used during the processing of mother bags and intermediates. The facility began to clean up its act, and by January 2013, no critical or major deficiencies were found.

“Although a number of critical and major concerns have been recorded over the years, the latest inspections showed that satisfactory improvements have been made to processes and procedures,” an MHRA spokesman said. “We will continue with our inspection regime to ensure these improvements are maintained — as is the case with any premise we enforce.”

The spokesman said no further enforcement action is planned against the companies at this stage. He added that regulatory penalties are separate from criminal sanctions. The convictions do not have immediate license implications.

Meanwhile, the FDA earlier this year upgraded its rating on Fresenius’ APP Pharmaceuticals New York plant, clearing the facility, which had been troubled by pest problems, to produce new drugs for Fresenius’ Kabi arm.

The plant, located in Grand Island, N.Y., was upgraded from official action indicated to voluntary action indicated.

Fresenius received the OAI status as the result of a 2012 warning letter that faulted the company for a litany of quality violations, including insects found in the manufacturing area during a 2011 inspection.

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